# K150427: Vantage Titan 1.5T, V3.1, MRT-1510

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Apr 17, 2015 after 57 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K002531 (2000). 14 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120638: Vantage Titan, Toshibamedical Systems Corporation (2012) Summary page 4.
- K141472: Vantage Elan, Toshiba America Medical Systems, In.C (2014) Summary page 7.
- K143008: Vantage Titan 3T, Toshibamedical Systems Corporation (2015). Cleared while this submission was under review Summary page 7.

## Most influential descendants
- K160632: Vantage Titan 1.5T, MRT-1510, V3.6 Software (2016), 17 descendants of its own
- K170412: Vantage Titan 1.5T, MRT-1510, M-Power GX (2017), 16 descendants of its own
- K182282: Vantage Orian 1.5T, MRT-1550, V4.5 (2018), 14 descendants of its own
- K193021: Vantage Orian 1.5T, MRT-1550, V6.0 (2020), 12 descendants of its own
- K202210: Vantage Orian 1.5T, MRT-1550, V6.0 (2020), 7 descendants of its own

## Indications for use
Vantage Titan systems are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this system is capable of non-contrast enhanced imaging, such as MRA. MRI (magnetic resonance imaging) images correspond to the spatial distribution of protons (hydrogen nuclei) that exhibit nuclear magnetic resonance (NMR). The NMR properties of body tissues and fluids are: • Proton density (PD) (also called hydrogen density) • Spin-lattice relaxation time (T1) • Spin-spin relaxation time (T2) • Flow dynamics • Chemical Shift Contrast agent use is restricted to the approved drug indications. When interpreted by a trained physician, these images yield information that can be useful in diagnosis.

Source page: https://510kreport.com/device/K150427
Methodology: https://510kreport.com/methodology